For adults with moderately to severely active ulcerative colitis and Crohn’s disease

Indications

Adult Ulcerative Colitis (UC) ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid‐free remission.
Adult Crohn’s Disease (CD) ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

ENGINEERED FOR UC AND CD

For patients with moderately to severely active CD

Efficacy data from CD
Trials I, II, and III

Clinical remission at Weeks 6 and 521

Entyvio efficacy in CD: Clinical remission at Weeks 6 and 52 chart Entyvio efficacy in CD: Clinical remission at Week 6 chart Entyvio efficacy in CD: Clinical remission at Week 52 chart
  • At Week 6, 31% (n=220) of patients taking Entyvio achieved clinical response versus 26% (n=148) with placebo (P=NS) (primary end point, CD Trial I)3
  • In a separate study, 15% (n=158) of patients taking Entyvio who had a suboptimal response to ≥1 anti-TNFα therapy achieved clinical remission at Week 6 versus 12% (n=157) with placebo (P=NS) (primary end point, CD Trial II)1

CD Trials I and II: Two randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active CD who had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy. In CD Trial I (N=368), patients were randomized (3:2) to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0 and 2. The primary end point for CD Trial I was the proportion of patients with clinical remission (CDAI score ≤150) at Week 6. Another primary end point, the difference in percentage of patients who demonstrated clinical response (≥100-point decrease in CDAI score from baseline), was not statistically significant at Week 6. In CD Trial II (N=416), a majority (76%) of enrolled patients had an inadequate response, loss of response, or intolerance to ≥1 TNF blockers; this was the primary analysis population. The primary end point for CD Trial II was the proportion of patients achieving clinical remission (CDAI score ≤150) at Week 6. Treatment with Entyvio did not result in statistically significant improvement over placebo. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted in all trials.

CD Trial III: A randomized, double-blind, placebo-controlled study enrolled adult patients with moderately to severely active CD who had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or ≥1 anti-TNFα therapy. Patients (N=461) receiving Entyvio who demonstrated clinical response (≥70-point decrease in CDAI score from baseline) at Week 6 (from CD Trial I or an open-label cohort) were randomized (1:1:1) to receive either Entyvio 300 mg every 8 weeks, Entyvio 300 mg every 4 weeks, or placebo every 4 weeks. The primary end point for CD Trial III was the proportion of patients achieving clinical remission (CDAI score ≤150) at Week 52. Concomitant aminosalicylates, corticosteroids, and immunomodulators were permitted.

CD trials overview

Remission without steroids1

Entyvio efficacy in CD: Steroid-free remission at Week 52. 2x as many patients achieved steroid-free remission with Entyvio every 8 weeks vs placebo. Entyvio efficacy in CD: Steroid-free remission at Week 52. 2x as many patients achieved steroid-free remission with Entyvio every 8 weeks vs placebo. Entyvio efficacy in CD: Steroid-free remission at Week 52. 2x as many patients achieved steroid-free remission with Entyvio every 8 weeks vs placebo.
*
Steroid-free remission: Assessed in the subgroup of patients who were receiving steroids at baseline and who were in clinical response (≥70-point decrease in CDAI score from baseline) at Week 6. Steroid-free remission was defined as the proportion of patients in this subgroup who discontinued steroids by Week 52 and were in clinical remission at Week 52.

CD Trials I and III Overview1

  • Two randomized, double-blind, placebo-controlled studies enrolled adult patients with moderately to severely active CD
  • Corticosteroids were tapered after Week 6; in the United States, immunosuppressants were discontinued after Week 6
See more study design information

Patient population

  • Patients had failed* at least one conventional therapy, including corticosteroids, immunomodulators, and anti-TNFα therapy
  • Patients who had received natalizumab ever in the past or a TNF blocker in the past 60 days were excluded from enrollment
Entyvio study overall population Entyvio study overall population

Treatment arms

  • Entyvio: Entyvio 300-mg infusion + concomitant therapies
  • Placebo: placebo saline infusion + concomitant therapies
Selected baseline
characteristics of patients
CD Trials10
Mean age 36.1 years
Mean disease duration 9.0 years
Mean CDAI score 324
CD Trial I1   CD Trial III1
Concomitant medications
Corticosteroids 49% 59%
Immunomodulators 35% 31%
Aminosalicylates 46% 41%
Prior anti-TNFα therapy failures* 48% 51%

CD Trial I1,10

CD Trial III1,10

Study design: 2 cohorts with primary end point evaluation at Week 6

Study design: Patients receiving Entyvio in cohorts 1 and 2 who achieved clinical response at Week 6 were randomly assigned to continue receiving Entyvio every 4 or 8 weeks or placebo every 4 weeks for up to 52 weeks

Entyvio efficacy in CD: Study design flow chart Entyvio efficacy in CD: Study design flow chart

Week 6 end points

Primary outcomes
Clinical remission = 
CDAI ≤150
Clinical response (P=NS) = 
≥100-point decrease
in CDAI from baseline

Week 52 end points

Primary outcomes Secondary outcomes
Clinical remissionII Clinical response
Corticosteroid-free clinical remission**
*
Inadequate response, loss of response, or intolerance to TNF blockers or immunomodulators; or inadequate response, intolerance, or dependence on corticosteroids.
Data from patients receiving blinded and open-label Entyvio treatment at Weeks 0 and 2 (prior to entry into CD Trial III) are included.
Concomitant therapies included aminosalicylates, steroids, and/or immunomodulators.
§
The Entyvio Q4W dosing regimen did not demonstrate additional clinical benefit over the Q8W dosing regimen. The Q4W dosing regimen is not the recommended dosing regimen.
||
Clinical remission = CDAI ≤150.
Clinical response = ≥100-point decrease in CDAI from baseline.
**
Assessed in the subgroup of patients who were receiving corticosteroids at baseline and who were in clinical response at Week 6 (n=82 for placebo, and n=82 for Entyvio Q8W). Corticosteroid-free clinical remission was defined as the proportion of patients in this subgroup who discontinued corticosteroids by Week 52 and were in clinical remission at Week 52.

CD Trial II Overview1

  • 416 enrolled patients were divided into 2 subpopulations: patients who had failed ≥1 anti-TNFα therapy (76%) and patients who were anti-TNFα naïve (24%)
  • Participants were randomized to receive Entyvio 300 mg or placebo by intravenous infusion at Weeks 0, 2, and 6
See more study design information

Patient population

  • Patients had failed* at least one conventional therapy, including corticosteroids and immunomodulators (in addition to anti-TNFα therapy)
  • Patients who had received natalizumab ever in the past or a TNF blocker in the past 60 days were excluded from enrollment

Treatment arms

  • Entyvio: Entyvio 300-mg infusion + concomitant therapies
  • Placebo: placebo saline infusion + concomitant therapies
Selected baseline
characteristics of patients
CD Trial II1,3
Mean age 37.9 years
Mean disease duration 10.3 years
Mean CDAI score 308
Concomitant medications
Corticosteroids 54%
Immunomodulators 34%
Aminosalicylates 31%
Prior anti-TNFα therapy failures* 76%
76% of patients in CD Trial II had an inadequate response, loss of response, or intolerance to one or more TNF blockers 76% of patients in CD Trial II had an inadequate response, loss of response, or intolerance to one or more TNF blockers

Study design: Patients were randomized in a double-blinded fashion (1:1) to receive either placebo or Entyvio 300 mg at Weeks 0, 2, and 6

*
Inadequate response, loss of response, or intolerance to TNF blockers or immunomodulators; or inadequate response, intolerance, or dependence on corticosteroids.
Concomitant therapies included aminosalicylates, steroids, and/or immunomodulators.
Clinical remission = CDAI ≤150.

IMPORTANT SAFETY INFORMATION

Expand
  • ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
  • Infusion‐related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
  • Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
  • Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
  • There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
  • Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non‐live vaccines and may receive live vaccines if the benefits outweigh the risks.
  • Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

Indications

Adult Ulcerative Colitis (UC)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid‐free remission.

Adult Crohn’s Disease (CD)

ENTYVIO (vedolizumab) is indicated in adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

Please see full Prescribing Information, including Medication Guide.

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